A Multicentre Pilot Study of Midline Catheter's Tip at a Different Position in Antimicrobial Therapy
- Conditions
- Infection
- Interventions
- Device: Shu Bei Kang (China) Midline Catheters
- Registration Number
- NCT04601597
- Lead Sponsor
- Sir Run Run Shaw Hospital
- Brief Summary
The research protocol was based on assigning patients to three different catheter tip groups and then observing the relationship between the tip and catheter-related complications when infusing antimicrobial agents.
- Detailed Description
A prospective case-control observation study method was adopted. The investigators of each center included patients who met the inclusion and exclusion criteria and were fully informed about the content of the study, possible benefits, and risks. After obtaining informed consent, the patients were included in the method of continuous sampling and convenient sampling. According to the method of random control, the patients were grouped. In the control group, the length of catheter insertion is measured from the pre-puncture point to the shoulder or armpit. In experimental group 1, the catheter insertion length is measured from the pre-puncture point to the midpoint of the clavicle, and in the experimental group, 2 catheter insertion length is measured from the pre-puncture point to the sternoclavicular joint. With a single-blind design, patients do not know the enrollment situation. The catheter was inserted by a full-time specialist nurse of intravenous therapy under ultrasound guidance combined with the modified Seedinger technique. The catheter was inserted according to the length of different measurement methods in different groups. After the catheter was inserted, an X-ray examination was performed to determine the catheter tip position again. Data collection and follow-up observation will be conducted by researchers who have been uniformly trained. Record the baseline data of the patients in the group before catheterization, record the insertion status during catheterization, record the patient's catheter use and catheter sealing frequency every day during catheter placement, and evaluate catheter function and complications until extubation daily.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 330
Expected intravenous infusion time over 1 week In line with the indications for the use of medium-length catheters More than 18 years old Full consciousness Signed the study informed consent
Source of infection at the catheter insertion site History of radiation therapy, history of thrombosis, history of trauma or vascular surgery at the site of catheterization Treatment requires input of irritating or hyperosmolar solutions Patients who need to be discharged with a catheter
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description The catheter tip was placed in the subclavian vein. Shu Bei Kang (China) Midline Catheters The pre-placement catheter length measured through the body surface was greater than the actual length. Therefore, 2 cm was subtracted from the pre-puncture point to the ipsilateral sternoclavicular joint to calculate the effective catheter pre-placement length. the catheter tip was located distal to the axillary vein. Shu Bei Kang (China) Midline Catheters The measurement method of catheter pre-placement length was as follows: in cases where the catheter was punctured from the basilic and brachial veins, the distance from the pre-puncture point to the intermuscular sulcus of the ipsilateral deltoid muscle and pectoralis major muscle was measured (not surpassing the intermuscular sulcus and not reaching the axilla); however, the distance from the pre-puncture point to the ipsilateral sub shoulder or axilla was measured. The tip of the catheter was placed in the axillary vein of the chest wall. Shu Bei Kang (China) Midline Catheters The pre-placement length of the catheter was measured by subtracting 3-4 cm from the distance between the puncture point and ipsilateral midclavicular line. This adjustment was intended to prevent the catheter tip from entering the subclavian vein.
- Primary Outcome Measures
Name Time Method Rate of Phlebitis through study completion, an average of 4 weeks Prolonged veins appear red, swollen, hot, and painful, with severe cord-like changes and indurations when touching. Mechanical phlebitis, infectious phlebitis, and thrombophlebitis are collected as phlebitis data
Rate of Catheter-Related Infection through study completion, an average of 4 weeks Including local infection of the puncture site and catheter-related blood stream infection (Catheter-Related Blood stream Infection, CRBSI). Local infection refers to redness, swelling and pain around the puncture point, or even pus; Catheter-associated bloodstream infection: refers to patients with indwelling catheters who develop bacteremia and draw blood cultures through peripheral veins for at least one positive result, accompanied by fever (\> 380C), chills, or hypotension. Other clear sources of bloodstream infection.
Rate of Bleeding through study completion, an average of 4 weeks Bloody fluid still leaks out of catheter puncture 48 hours after catheter insertion
Rate of Catheter-related thrombosis through study completion, an average of 4 weeks The PICC-related thrombosis in this study refers only to symptomatic thrombi, excluding asymptomatic thrombi. Catheter-related venous thrombosis was diagnosed by color Doppler ultrasound examination when the clinical manifestations were related symptoms such as swelling and pain in the upper arm of the catheterization side.
Rate of Dislodgment through study completion, an average of 4 weeks The catheter slipped more than 3cm above the exposed length of the first tube placement
Rate of exudation through study completion, an average of 4 weeks There is a slight yellow or clear liquid leakage from the catheter puncture site
Rate of Occlusion through study completion, an average of 4 weeks According to the degree, it is divided into complete occlusion and incomplete occlusion. When there is resistance or difficulty in flushing the tube, poor blood withdrawal or even no blood return can indicate that the catheter is incompletely occlusion; if it is difficult to flush the tube and draw blood, it can indicate that the catheter is completely occlusion.
- Secondary Outcome Measures
Name Time Method Dwell time through study completion, an average of 4 weeks Time from tube insertion to extubation, in days
Endometrial conditions 24 hours before intubation and after extubation Ultrasound examination of the vascular intima before catheterization and within 24 hours after extubation was performed. No abnormality in the intimal smoothness was negative, and abnormalities in the intimal smoothness and hyperplasia were positive.
Trial Locations
- Locations (6)
Kunshan first people's Hospital
🇨🇳Suzhou, Jiangsu, China
Sir Runrun Shaw Hospital
🇨🇳Hangzhou, Zhejiang, China
Zhongshan Hospital Affiliated to Xiamen University
🇨🇳Xiamen, Fujiang, China
Changshu first people's Hospital
🇨🇳Suzhou, Jiangsu, China
Liaoning Provincial People's Hospital
🇨🇳Shenyang, Liaoning, China
Zhejiang Second Hospital Affiliated to Medical College of Zhejiang University
🇨🇳Hangzhou, Zhejiang, China